FDA Inspection 672260 — University of Vermont Health Network - Adirondack Blood Center
The FDA completed an inspection of University of Vermont Health Network - Adirondack Blood Center on July 22, 2010 in Plattsburgh, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 22, 2010
- Fiscal Year
- 2010
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Plattsburgh, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 15030 | 21 CFR 606.60(b) | Equipment calibration frequency |
| 160 | 21 CFR 606.160(a)(1) | Person performing, test results, interpretation |
| 205 | 21 CFR 640.3(f) | Donations in less than eight weeks |
| 246 | 21 CFR 640.25(a) | Storage temps./agitation |
| 9225 | 21 CFR 606.171 | Biological product deviation report |